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namsa medical devices medical device biocompatibility fda iso 10993 medical device testing clinical biological evaluation regulatory postmarket medical devices leachables device in vitro shelf life 510(k) pma post-market sterilization chemical characterization clinical trial genotoxicity toxicity cytotoxicity material characterization validation material characterization & analytical chemistry markets food and drug administration get to market remote training series rts extractables/leachables code of federal regulations food drug and cosmetic act public health advisory risk assessment extractables market compliance emgp north american science associates emerging reprocessing processing get-to-market draft guidance tir aami global disinfection cleaning post market aami tir 12:2010 color additives colorants strategy tc194 irritation cfda meta analysis packaging validation enviornmental monitoring toxicology glp carcinogenicity thrombosis coagulation platelets hematology implant implantation ethylene oxide ethylene chlorhydrin design validation preclinical concept feasibility market approval certification safety evaluation safety bpmds biocompatibility and peformance of medical devices interim analysis interim analyses type i error type ii error acceptance review dcc biostatistic biostatistics clinical trials biostatistician statistical cdrh statisticians clinical research biological safety extraction characterization